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Apatinib for Advanced Biliary Carcinoma

Primary Purpose

Biliary Tract Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Biliary Tract Neoplasms focused on measuring biliary tract carcinoma, apatinib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients age between 18 and 70 years
Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC
Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine).
At least one measurable lesion as defined by RECIST 1.1
An Eastern Cooperative Oncology Group performance status of 0 to 2
Life expectancy ≥ 12 weeks
For those who received other anti-tumor treatment, the damage should have been restored, with the time interval from last dose of nitroso or mitomycin≥6 weeks and interval from last dose of other cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥4 weeks.
Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood ANC count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin < 1.5 x ULN, ALT and AST< 2.5 x ULN(< 5 x ULN for patients with live metastasis), serum creatinine≤1 x ULN，endogenous creatinine clearance rate >50ml/min
Women of reproductive age need to take effective contraceptive measures

Exclusion Criteria:

With other malignant tumor in 5 years，except for cured cervical carcinoma in situ or basal cell carcinoma.
Uncontrolled blood pressure on medication (140/90 mmHg); patients with > Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction
Symptomatic brain or meningeal metastasis
History of uncontrolled seizures, central nervous system dysfunction or mental disorder
Uncontrolled pleural or peritoneal effusion
Undergoing dialysis
Severe or uncontrolled infection
With multiple factors that affecting oral administration
Abnormal coagulation function or those receiving thrombolytics or anticoagulants
Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
Participation in other drug clinical trials within 4 weeks
Weight below 40kg
urine protein ≥2+

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

oral apatinib

Outcomes

Primary Outcome Measures

PFS

progression free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT03427242

First Posted

January 25, 2018

Last Updated

February 2, 2018

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03427242

Brief Title

Apatinib for Advanced Biliary Carcinoma

Official Title

A Phase II Study of Apatinib Treatment for Advanced Biliary Tract Carcinoma After Failure of the First-line Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase II open-label, one-arm, single-center study of apatinib for eligible patients with advanced biliary tract carcinoma after the first-line treatment failure. A total of 55 patients is planned for enrollment. The time for enrollment is from Nov 2017 to Nov 2020, the the follow-up will be ended after Nov 2021. Patients in the study would receive oral apatinib 500-750mg qd until progression of disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Neoplasms

Keywords

biliary tract carcinoma, apatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

apatinib

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment arm

Arm Type

Experimental

Arm Description

oral apatinib

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

oral apatinib 750mg qd

Primary Outcome Measure Information:

Title

PFS

Description

progression free survival

Time Frame

from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcome Measure Information:

Title

Description

overall survival

Time Frame

from the time signing of ICF until the date of death from any cause, assessed up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients age between 18 and 70 years Histologically confirmed advanced biliary tract carcinoma (BTC) or metastatic BTC Prior lack of response or intolerance to at least one chemotherapeutic regimens (including gemcitabine). At least one measurable lesion as defined by RECIST 1.1 An Eastern Cooperative Oncology Group performance status of 0 to 2 Life expectancy ≥ 12 weeks For those who received other anti-tumor treatment, the damage should have been restored, with the time interval from last dose of nitroso or mitomycin≥6 weeks and interval from last dose of other cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥4 weeks. Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood ANC count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin < 1.5 x ULN, ALT and AST< 2.5 x ULN(< 5 x ULN for patients with live metastasis), serum creatinine≤1 x ULN，endogenous creatinine clearance rate >50ml/min Women of reproductive age need to take effective contraceptive measures Exclusion Criteria: With other malignant tumor in 5 years，except for cured cervical carcinoma in situ or basal cell carcinoma. Uncontrolled blood pressure on medication (140/90 mmHg); patients with > Grade 1 coronary heart disease, cardiac arrhythmias or cardiac dysfunction Symptomatic brain or meningeal metastasis History of uncontrolled seizures, central nervous system dysfunction or mental disorder Uncontrolled pleural or peritoneal effusion Undergoing dialysis Severe or uncontrolled infection With multiple factors that affecting oral administration Abnormal coagulation function or those receiving thrombolytics or anticoagulants Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months Participation in other drug clinical trials within 4 weeks Weight below 40kg urine protein ≥2+

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chenchen Wang, MD

Phone

+8613774232040

wccnancy2003@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weijian Guo, MD

Organizational Affiliation

Shanghai Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenchen Wang, MD

Phone

+8613774232040

wccnancy2003@aliyun.com

First Name & Middle Initial & Last Name & Degree

Weijian Guo, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23786845

Citation

Cereda S, Belli C, Rognone A, Mazza E, Reni M. Second-line therapy in advanced biliary tract cancer: what should be the standard? Crit Rev Oncol Hematol. 2013 Nov;88(2):368-74. doi: 10.1016/j.critrevonc.2013.05.010. Epub 2013 Jun 17.

Results Reference

background

PubMed Identifier

20375404

Citation

Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

Results Reference

background

PubMed Identifier

23918952

Citation

Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

Results Reference

background

PubMed Identifier

26884585

Citation

Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

Results Reference

background

PubMed Identifier

26967384

Citation

Peng H, Zhang Q, Li J, Zhang N, Hua Y, Xu L, Deng Y, Lai J, Peng Z, Peng B, Chen M, Peng S, Kuang M. Apatinib inhibits VEGF signaling and promotes apoptosis in intrahepatic cholangiocarcinoma. Oncotarget. 2016 Mar 29;7(13):17220-9. doi: 10.18632/oncotarget.7948.

Results Reference

background

PubMed Identifier

34484431

Citation

Wang C, Huang M, Geng Q, Li W, Chang J, Tang W, Guo W. Apatinib for patients with metastatic biliary tract carcinoma refractory to standard chemotherapy: results from an investigator-initiated, open-label, single-arm, exploratory phase II study. Ther Adv Med Oncol. 2021 Aug 31;13:17588359211039047. doi: 10.1177/17588359211039047. eCollection 2021.

Results Reference

derived

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Apatinib for Advanced Biliary Carcinoma

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